Mechanisms Regulating Wound Vascularization

Gayle Gordillo

Status: Terminated

Conditions: Wounds and Injuries

Treatments: Procedure: Samples will be collected

Study type: Observational

Funder types: Other

Identifiers

NCT00737321

2008H0051

Details and patient eligibility

About

This pilot study is designed to assess the impact of ischemia/ diminished wound vascularization and stress on wound healing by comparing patterns of gene expression in specific cell types critical to wound healing biology, e.g. macrophages or endothelial cells.

Full description

Chronic wounds affect approximately 2% of the U.S. population at any given time. Animal models can not simulate the complex set of pre-existing conditions in each individual that results in failed wound healing. Therefore, human subjects must be used to obtain valid data. Adequate wound vascularization that permits blood vessels to deliver oxygen to the wound is a requirement for wound healing to occur. This protocol will attempt to gain greater understanding of the mechanisms of chronic wounds through 3 specific aims: 1) identify the angiogenic mechanisms in wound site macrophages, which are required for healing, 2) determine the impact of stress and glucocorticoid resistance on endothelial cell and macrophage biology and ultimately wound healing outcomes, 3) identify patterns of gene expression in wound endothelial cells that are found in healing versus non-healing wounds. This data will be correlated with the wound oxygenation status to determine the impact of wound vascularization on the observed biological responses.

Enrollment: 36 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-69 years
• ischemic wound group
• non-ischemic wound group
• diabetes with good glycemic control
• lower extremity wound

Exclusion criteria

• Age greater ≥ 70 years
• End stage renal disease
• Unable to provide informed consent
• Pregnant women
• Therapeutically anticoagulated
• Prisoners
• Periwound TcOM < 25mmHg
• Spinal cord injury
• Taking immunosuppressive medications
• Individuals with current diagnosis of a major psychiatric illness (e.g.schizophrenia,psychosis)
• Severe protein malnutrition- pre-albumin < 10 mg/dl or albumin < 2 g/dl
• Diabetes with poor glucose control-defined as hgb A1c > 8.4%

Trial design

36 participants in 2 patient groups

2- Diabetics without wound (s)

Description:

These group of subject will be control arm, included who have good glycemic control diabetic with HbA1c 8.4 or lower and also without any open wounds. Samples will be collected.

Treatment:

Procedure: Samples will be collected

1-Subjects with diabetes with wound

Description:

This group of subjects will have wound and come for couple of follow up visits for saliva collection, biopsy collection and blood draw.